Hepatitis Delta Serological Reagents

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT ANTI-DELTA EIA

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG QUALITATIVE/CONFIMATORY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT I1000 SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTI-HCV

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·HAVAB-M EIA DIAGNOSTIC KIT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AXSYM ANTIBODY TO HCV

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc Reagent Kit, Alinity i Anti-HBc Calibrator, Alinity i Anti-HBc Controls

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc IgM Reagent Kit (2xl00 Tests)

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM AFP (LIST 7A48)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX PSA

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·MURINER LUBRICATING & REWETTING DROPS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i HBsAg Qualitative II Reagent Kit (2x100 Tests), Alinity i HBsAg Qualitative II Reagent Kit (2x600 Tests), Alin

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AFP-EIA LABELING CHANGE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE